Komatsoulis Jhu

  • 729 views
Uploaded on

NCI case report form standardization activities in the Cancer Biomedical Informatics Grid

NCI case report form standardization activities in the Cancer Biomedical Informatics Grid

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
729
On Slideshare
0
From Embeds
0
Number of Embeds
0

Actions

Shares
Downloads
12
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. NCI Clinical Case Report Form (CRF) Standardization Activities George A. Komatsoulis, Ph.D. Deputy Director Center for Biomedical Informatics and Information Technology (CBIIT) National Cancer Institute
  • 2. “ A wonderful fact to reflect upon, that every human creature is constituted to be that profound secret and mystery to every other.” Charles Dickens: A Tale of Two Cities 1859
  • 3. Childhood Cancer: Dramatic Improvement in Survival *5-year relative survival rates, based on follow up of patients through 2003. Source: Surveillance, Epidemiology, and End Results Program, 1975-2003, Division of Cancer Control and Population Sciences, National Cancer Institute, 2006. 5 - Year Relative Survival Rates * Age Year of Diagnosis 0 - 4 Years 5 - 9 Years 10 - 14 Years 1975 - 1977 1996 - 2002 1975 - 1977 1996 - 2002 1975 - 1977 1996 - 2002 79.7 77.9 80.1 58.8 58.2 57.3
  • 4. High Participation in Clinical Research Winchester et al., CA Cancer J Clin 2001;51;119-130
  • 5. Childhood ALL: Molecular Sub-types Impact Risk Tsao et al. Modern Pathology (2004) 17: 832–839 Rubnitz and Pui, Oncologist ( 1997) 2 :374-380
  • 6. Childhood Cancer Treatment Demonstrates the New Molecular Medicine Model
    • Treatment is delivered in an environment that blends care and research
    • Researchers and practitioners are able to correlate experimental laboratory data with clinical data (treatment, history, pathology, outcome, etc.)
    • Clinical data are utilized to continuously evaluate outcomes
    • Researchers develop and refine evidence-based strategies at an individualized level
    • Care providers improve quality by adherence to care standards
    Information flow is critical… this model cannot be achieved without the ability to reuse and aggregate data in novel ways!
  • 7. Improving the Return on the Nation’s Investment in Cancer Research
    • Human Clinical Trials are of immense importance to providing new and improved treatments for patients, yet by their nature they have several undesirable traits including potential harm to patients and immense expense.
    • For these and other reasons, it is absolutely essential to maximize the return on investment (ROI) in human clinical research either by (1) decreasing the costs associated with trials or (2) increasing the amount of information extracted from any single clinical trial
    • Two primary mechanisms by which data sharing and data standards can aid in ROI:
      • Reduce the time and costs associated with setting up a clinical trial
      • Enhance the ability of other groups to reuse the data collected in one clinical trial (for example, in longitudinal studies)
    • In order to reuse data, it is necessary to have a thorough understanding of its meaning…
  • 8. “ And the Lord said, Behold, the people is one, and they have all one language; and this they begin to do; and now nothing will be restrained from them, which they have imagined to do. Go to, let us go down, and there confound their language, that they may not understand one another's speech.” Genesis , Chapter 11, 500-450 BCE “ What we have here is… failure to communicate” Strother Martin in Cool Hand Luke 1967
  • 9. Attribute Value Agent NSCNumber 007 Name Taxol
  • 10. Attribute Value NCI Meaning Agent A chemical compound administered to a human being to treat an existing disease or condition, or prevent the onset of a disease or condition nSCNumber 007 Identifier given to a chemical compound by the US Food and Drug Administration (FDA) Nomenclature Standards Committee (NSC) Name Taxol Name of a chemical compound given by the NCI Cancer Therapeutics Evaluation Program (CTEP)
  • 11. Attribute Value NCI Meaning CIA Meaning Agent A chemical compound administered to a human being to treat an existing disease or condition, or prevent the onset of a disease or condition A sworn intelligence agent; a spy nSCNumber 007 Identifier given to a chemical compound by the US Food and Drug Administration (FDA) Nomenclature Standards Committee (NSC) Identifier given to an intelligence agent by the National Security Council Name Taxol Name of a chemical compound given by the NCI Cancer Therapeutics Evaluation Program (CTEP) Code name given to intelligence agents by the Central Intelligence Agency (CIA)
  • 12. Attribute Value NCI Metadata CIA Metadata Agent A chemical compound administered to a human being to treat an existing disease or condition, or prevent the onset of a disease or condition A sworn intelligence agent; a spy nSCNumber 007 Identifier given to a chemical compound by the US Food and Drug Administration (FDA) Nomenclature Standards Committee (NSC) Identifier given to an intelligence agent by the National Security Council Name Taxol Name of a chemical compound given by the NCI Cancer Therapeutics Evaluation Program (CTEP) Code name given to intelligence agents by the Central Intelligence Agency (CIA)
  • 13. Empowering Data Reuse: Semantic Metadata
    • Reuse therefore requires ‘semantic metadata’; information that conveys what is being recorded and what constitutes a valid response for that particular element.
    • An international standard (ISO/IEC 11179) exists for such semantic metadata, this standard has been leveraged to create the cancer Data Standards Repository (caDSR).
    • The basic unit of metadata in the caDSR is a Common Data Element or CDE.
  • 14. The ISO 11179 Model in the caDSR
  • 15. The cancer Data Standards Repository (caDSR)
  • 16. Enterprise Vocabulary Service (EVS)
  • 17. Square Pegs and Round Holes
  • 18. Clinical Trials Working Group
    • National Cancer Advisory Board Group
    • Report “Re-structuring the National Cancer Clinical Trials Enterprise” (June 2005)
    • Remit: advise on “whether, andin what ways, the NCI-supported national clinical trials enterprise should be restructured to realize the promise of molecular medicine for advancing oncologic clinical practice in the21stCentury”
    • Twenty-two Initiatives
  • 19. Clinical Trials Working Group (CTWG) CTWG Goal CTWG Initiative Enhanced Coordination Establish a comprehensive database containing regularly-updated information on all NCI-funded clinical trials Enterprise Wide Standardization Achieve industry and FDA concurrence on standard Case Report Forms incorporating Common Data Elements Promote establishment of national clinical trial information technology infrastructures that are fully interoperable with NCI’s cancer Biomedical Informatics Grid (caBIG™) Develop a credentialing system for investigators and sites that is recognized and accepted by NCI, industry sponsors, clinical investigators, and clinical trial sites
  • 20. Characteristics of a library of standardized CRF modules
    • A library of modules, containing questions to be used in CRFs in all oncology trials
    • These modules would not be a set of required forms, per se , instead they contain the set of data elements that must be collected during a trial
    • These modules do not restrict investigators from collecting additional information
  • 21. “ Genius is one percent inspiration and ninety-nine percent perspiration” Thomas Alva Edison, Harper’s Monthly , September 1932
  • 22. Case Report Forms Based on Common Data Elements (CDEs)
  • 23. CRF Standardization Global Process
    • Inventory
      • Existing case report forms (whether harmonized or not)
      • Initial inventory from forms whose metadata are captured in the cancer Data Standards Repository (caDSR)
    • Prioritize
      • Based on the inventory and Steering Committee feedback, select the areas for harmonization.
    • Analyze and Harmonize (Working Groups)
      • Come to agreement on the core questions associated with a specific CRF
      • Reach out to the community for additional CRFs in this area
      • Come to agreement on the core data to be collected on this specific CRF
    • Community Input
      • Important to ensure acceptance of the harmonized CRFs
      • CRF SIG and caBIG program will provide the mechanism to receive input
    • Standardization
      • Approval by stakeholders
  • 24. CRF Analysis Methodology
    • Part I: Question intent
    • Part II: Partition
      • Mandatory
      • Conditional
      • Optional
      • Non-harmonized
    • Part III: Detailed Analysis
    • Important caveat: We should not be creating new questions that have not been asked on an existing CRF
  • 25. CRF Questions: Partition Issues
    • Regulatory Requirements
      • FDA Representatives, Compliance Officers, Regulatory Affairs Officers
    • Sponsor Requirements
      • NCI Division Representatives, Principal Investigators
    • Data Reuse Requirements
      • Principal Investigators, Data Managers, Biostatisticians, Oncology Nurses and the rest of our community
    • External Standards Requirements
      • Standards Organizations (CDISC, HL7, FHA, etc.)
  • 26. CRF Questions: Detailed Analysis
    • Question by question (or CDE by CDE) analysis
    • Must harmonize:
      • Question meaning
      • Question text
      • Valid responses
    • General Strategy (Proposed order of precedence)
        • Reuse an existing CDE
        • Create a hybrid CDE
        • Create a new CDE
    • The same constraints apply to CDE level analysis
  • 27. Demography: A Definition
    • Pronunciation: di-'mä-gr&-fE
    • Function: noun
    • Etymology: French démographie, from Greek dEmos people + French -graphie –graphy
    • Definition: The statistical study of human populations especially with reference to size and density, distribution, and vital statistics
  • 28. Sources of CRFs: Demography Analysis
    • CTEP Phase 2 Enrollment
    • CTEP Phase 3 Enrollment
    • DCP Enrollment Form
    • C3D (CCR) Enrollment
    • ACOSOG Registration
    • CALGB Registration
    • GeminX Demographics
    • NSABP Registration
    • NSABP Entry
    • OHSU Enrollment
    • OHSU 1754 Enrollment
    • OHSU Registration
    • RTOG Registration
    • SWOG Registration
    • SWOG S0522 Registration
    • UNMC Enrollment
    • CDASH Demography
  • 29. Working Group Members
    • Sharon Elcombe, Mayo (Informatician)
    • Rhonda Facile, CDISC (Data Standards)
    • Howard Fingert, Pfizer (Clinician)
    • Lara Fournier, Oregon Health Science University (Informatician)
    • Marsha Ketcham,Univ. of Nebraska Cancer Center (Clinical Research Coordinator)
    • Darlene Kiniry, NSABP (Informatician)
    • George Komatsoulis, NCI – Informatician
    • Brenda Maeske, SAIC/CBIIT (Data Element Specialist)
    • Beverly Meadows, DCP (Oncology Nurse)
    • Jon Neville, Cpath (Drug Policy)
    • Susan Pannoni, City of Hope ()
    • Stephine Wasielewsky, Univ. of Wisconsin Cancer Center
    • Dianne Reeves, CBIIT (Oncology Nurse)
    • Aaron Seib, OmnicommSystems (Informatician)
    • Ann Setser, CTEP (Oncology Nurse)
    • Adel Taweel, Univ. of Birmingham, UK (Informatician)
    • Susan Varghese, BAH
    • Gary Walker, Quintiles/CDASH
  • 30. Actions to date
    • Harmonized Demography Module created by Working Group
    • Module reviewed within caBIG Clinical Trial Management Systems (CTMS) workspace
    • Module approved for wider review by NCI Clinical/Translational Operating Committee (CTROC)
    • Module circulated for wide review:
      • caBIG listservs
      • CTMS Steering Committee
      • Cancer Policy Today and other ASCO vehicles
    • Comments received and analyzed
    • Presented to CTROC, governing board for CTMS Working Group activities at NCI
      • CTROC Approved Demography Module as an NCI Standard
    • Some implementation Details Still to be determined
  • 31. CDASH and caBIG: Complementary Activities
    • The CDASH initiative that is managed by the CDISC consortium and the NCI/caBIG Case Report Form (CRF) Harmonization activity are both concerned with harmonizing and standardizing the collection of data in clinical trials, but their focus and granularity differ somewhat
      • CDASH’s efforts are focused on elements that are common to all clinical trials
      • caBIG is focused on trials in the oncology space
    • NCI/caBIG CRF modules will (at a minimum) include all CDASH “mandatory” questions plus additional content that is essential in the oncology space.
    NCI “mandatory” CDASH “ mandatory”
  • 32. caBIG/CDASH Collaboration Mechanisms
    • Mutual Staffing Support
      • NCI/caBIG is providing staff to many CDASH “streams”
      • CDASH project director (Rhonda Facile) sits on the NCI Task Force that manages the CRF project
    • Project Inputs
      • Where CDASH streams complete before NCI CRF modules are defined, the CDASH module is one of the inputs to the NCI working groups and vice versa
    • Terminology and Metadata Support
      • NCI Enterprise Vocabulary Services (EVS) provides terminology support for CDISC/CDASH
      • NCI cancer Data Standards Repository (caDSR) provides a repository to maintain CDISC/CDASH data elements
  • 33. ἄνδρα μοι ἔννεπε, μοῦσα, πολύτροπον, ὃς μάλα πολλὰ πλάγχθη, ἐπεὶ Τροίης ἱερὸν πτολίεθρον ἔπερσεν Ὅμηρος : Οδύσσεια “ Tell me, O Muse, of the man of many devices, who wandered full many ways after he had sacked the sacred citadel of Troy” Homer: The Odyssey (8 th Century BCE)
  • 34. Status: Round 1
    • Round 1: Demography Module
      • Reviewed and Approved
      • Form template with instructions are in the caDSR
      • Ready for implementation
    • Entered Early Adopter Phase November 1, 2008
  • 35. Status: Round 2
    • Round 2 Modules:
      • Adverse Events
      • Medical History
      • Physical Exam
      • Participant Identification
      • Registration
      • Enrollment
      • Protocol Deviations
    • Completed Community review September 5, 2008
    • Comments reconciled by Workgroup October 3, 2008
    • Presented to CTROC for review
  • 36. Status: Round 3
    • Round 3 Modules:
      • Agents
      • Laboratory Tests/Results
      • Staging/Extent of Disease
      • Outcome Measures
    • Kick-off Teleconference September 4, 2008
    • Groups will run approximately three to four months
  • 37. Implementation of Subsequent Modules
    • Begin successive modules every 3 to 4 months
    • Observe the same schedule
      • Community Review
      • Reconciliation of comments
      • Submission to CTROC for approval
      • Early adoption to gather more pragmatic information
      • Close early adoption and make module changes
      • Release module(s)
      • Mandate widespread use three months later
  • 38. CRF Planning Matrix
  • 39. Change Management and Review
    • Every calendar year the total library of CRFs will be reviewed for changes
    • Older versions will be appropriately archived yet accessible as required
    • caBIG ® will provide support for updates and release with version control
    • Modifications will be requested and changes will be vetted by community and the NCI.
    • All CRF Versions will be provided and Maintained on the NCI website
    • The Demography CRF module will become a candidate for review in April 2010.
  • 40. Thank You
    • Study Conduct Task Force
      • Don Connelly (MN)
      • Sharon Elcombe (Mayo)
      • Lara Fournier (OHSU)
      • Andrea Hwang (Irvine)
      • Bob Lanese (Case)
      • Joyce Niland (City of Hope)
    • SAIC CDE Curation Team
      • Janice Chilli
      • Mary Cooper
      • Tommie Curtis
      • Kathleen Gundry
      • Brenda Maeske
    • CBIIT
      • Ken Buetow
      • Dianne Reeves
      • Ed Helton
      • John Speakman
      • Denise Warzel
      • Krishnakant (Avinash) Shanbhag
    • BAH CTMS Support
      • Ryan Budd
      • Riki Ohira
      • Susan Varghese
      • Derek Walker
    • CDASH
      • Rhonda Facile
      • Gary Walker
    • CCCT
      • Beverly Meadows
      • Lee Ann Jensen
      • Sheila Prindiville
    • caBIG CTMS Steering Committee
    • American Society for Clinical Oncology (ASCO)
    • Workgroup Participants
    “ the bravest are surely those who have the clearest vision of what is before them, glory and danger alike, and yet notwithstanding, go out to meet it.” Thucydides, c. 400 BCE